Annovis Bio, Inc. (NYSE:ANVS) ("Annovis" or the "Company"), a Phase 3 clinical-stage biotechnology company developing the investigational oral therapy, buntanetap, for neurodegenerative diseases such as Alzheimer’s disease (AD) and Parkinson’s disease (PD), today announced full enrollment of its pivotal Phase 3 trial (NCT06709014) evaluating buntanetap in patients with early AD. The trial enrolled 850 patients with pTau217-confirmed AD pathology across 83 clinical sites in the US.

"Reaching this level of enrollment, well above our original goal, reflects the trust patients and families living with this disease have placed in our work, and that is not something we take for granted," said Maria Maccecchini, Ph.D., Founder, President and CEO of Annovis. "This achievement is the product of outstanding trial design, management, and execution led by Cheng Fang, our CSO, and Sarah MacCallum, our VP of Clinical Operations, built from the ground up. I am deeply grateful to them and the entire Annovis team for their professionalism and passion in conducting this study according to the highest standards."

The pivotal Phase 3 AD study is a randomized, placebo-controlled, double-blind dual clinical trial designed with two pre-specified readouts: a 6-month analysis of symptomatic effects and an 18-month analysis of disease-modifying effects of daily oral buntanetap (30mg). The trial has recruited patients diagnosed with early AD (MMSE 20-28) who are positive for blood biomarker pTau217, which indicates Alzheimer's pathology in the brain. The primary endpoints will assess changes in cognition (ADAS-Cog13) and function (ADCS-iADL). This dual design will produce two distinct data readouts, each intended to support a separate regulatory submission for a New Drug Application (NDA).

Next Milestones

With the last patient expected to complete the 6-month treatment period in January 2027, followed by data cleaning and analysis, Annovis anticipates the following near-term milestones:

  • Q1 2027: 6-month symptomatic top-line data readout
  • Q1 2028: 18-month disease-modifying top-line data readout
  • Regulatory submissions: The Company has already begun preparations for NDA submissions to the U.S. Food and Drug Administration (FDA), building on guidance received during prior FDA interactions, to position Annovis for submission shortly after each respective readout

     

"That level of enthusiasm from the patient community underscores how urgently a new treatment for Alzheimer's is needed, and how eager people affected by the disease are to help advance it toward the finish line," said Cheng Fang, Ph.D., CSO at Annovis. "High enrollment also strengthens the statistical power of our dataset. Combined with the FDA-aligned protocol, we are executing this trial according to regulatory requirements as we approach this important moment for our company and the Alzheimer's community."

"This time last year, our trial had 50 patients enrolled; today, the number stands at 850. We want to thank every patient, caregiver, and investigator who made this progress possible," said Sarah MacCallum, VP, Clinical Operations at Annovis. "Seamless execution across so many clinical sites and consistent follow-up with every patient throughout this rigorous enrollment process – all required great effort from every party involved, and we are thankful to everyone who helped us reach this milestone."